Skip to main content

Research Repository

Advanced Search

Discrepancies between registration and publication of randomised controlled trials: an observational study

Walker, Kate F.; Stevenson, Graham; Thornton, Jim

Authors

KATE WALKER Kate.Walker@nottingham.ac.uk
Clincial Associate Professor Inobstetrics / anne Mclaren Fellow

Graham Stevenson

JIM THORNTON jim.thornton@nottingham.ac.uk
Professor of Obstetrics and Gynaecology



Abstract

Abstract
OBJECTIVES:
To determine the consistency between information contained in the registration and publication of randomised controlled trials (RCTs).
DESIGN:
An observational study of RCTs published between May 2011 and May 2012 in the British Medical Journal (BMJ) and the Journal of the American Medical Association (JAMA) comparing registry data with publication data.
PARTICIPANTS AND SETTINGS:
Data extracted from published RCTs in BMJ and JAMA.
MAIN OUTCOME MEASURES:
Timing of trial registration in relation to completion of trial data collection and publication. Registered versus published primary and secondary outcomes, sample size.
RESULTS:
We identified 40 RCTs in BMJ and 36 in JAMA. All 36 JAMA trials and 39 (98%) BMJ trials were registered. All registered trials were registered prior to publication. Thirty-two (82%) BMJ trials recorded the date of data completion; of these, in two trials the date of trial registration postdated the registered date of data completion. There were discrepancies between primary outcomes declared in the trial registry information and in the published paper in 18 (47%) BMJ papers and seven (19%) JAMA papers. The original sample size stated in the trial registration was achieved in 24 (60%) BMJ papers and 21 (58%) JAMA papers.
CONCLUSIONS:
Compulsory registration of RCTs is meaningless if the content of registry information is not complete or if discrepancies between registration and publication are not reported. This study demonstrates that discrepancies in primary and secondary outcomes and sample size between trial registration and publication remain commonplace, giving further strength to the World Health Organisation's argument for mandatory completion of a minimum number of compulsory fields.

Citation

Walker, K. F., Stevenson, G., & Thornton, J. (2014). Discrepancies between registration and publication of randomised controlled trials: an observational study. Journal of the Royal Society of Medicine, 5(5), doi:10.1177/2042533313517688

Journal Article Type Article
Publication Date May 1, 2014
Deposit Date Feb 18, 2016
Publicly Available Date Feb 18, 2016
Journal Journal of the Royal Society of Medicine Open
Print ISSN 0141-0768
Electronic ISSN 1758-1095
Publisher SAGE Publications
Peer Reviewed Peer Reviewed
Volume 5
Issue 5
DOI https://doi.org/10.1177/2042533313517688
Public URL http://eprints.nottingham.ac.uk/id/eprint/31820
Publisher URL http://shr.sagepub.com/content/5/5/2042533313517688
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by-nc/4.0

Files

JRSM Open-2014-Walker-.pdf (156 Kb)
PDF

Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by-nc/4.0





You might also like



Downloadable Citations